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Study of Secukinumab With 2 mL Pre-filled Syringes (ALLURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748863
Recruitment Status : Completed
First Posted : April 22, 2016
Results First Posted : June 26, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Placebo Drug: Secukinumab 2 mL form Drug: Secukinumab 1 mL form Phase 3

Detailed Description:
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
Drug: Placebo
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48

Experimental: Secukinumab 2 mL form
Secukinumab 300 mg, provided in a 2 mL pre-filled syringe
Drug: Secukinumab 2 mL form
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Active Comparator: Secukinumab 1 mL form
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
Drug: Secukinumab 1 mL form
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48




Primary Outcome Measures :
  1. Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

    Number of participants who achieved ≥ 75% reduction in PASI compared to baseline

    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).


  2. Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

    The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.

    Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline



Secondary Outcome Measures :
  1. Participants With PASI 90 After 12 Weeks of Treatment [ Time Frame: 12 weeks ]
    Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline

  2. Number of Participants With PASI 100 Response After 12 Weeks of Treatment [ Time Frame: 12 weeks ]
    Participants who achieved 100% reduction in PASI compared to baseline

  3. Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response [ Time Frame: up to week 52 ]
    PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects eligible for inclusion in this study must fulfill all of the following criteria:

  1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
  2. Men or women of at least 18 years of age at the time of Screening.
  3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
  4. Moderate to severe psoriasis as defined at Randomization by:

    • PASI score of 12 or greater, and
    • IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

    • Topical treatment and/or
    • Phototherapy and/or
    • Previous systemic therapy

Exclusion Criteria:

  1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
  2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.

    Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.

  3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
  4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
  5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  7. History of hypersensitivity to any of study drug constituent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748863


Locations
Show Show 52 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] September 11, 2018
Study Protocol  [PDF] February 22, 2016

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02748863    
Other Study ID Numbers: CAIN457A2323
First Posted: April 22, 2016    Key Record Dates
Results First Posted: June 26, 2019
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
psoriasis
secukinumab
pre-filled syringes
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs